Nov. 23, 2010 -- Johnson & Johnson says it has ordered a voluntary recall of about 4.8 million packages of children’s medicines due to “insufficiencies” in the manufacturing process.
She says the medicines are not dangerous and that the recalls are being done at the wholesale and retail levels, including drugstores.
Consumers may keep taking the medications, she says.
No Adverse Events Reported
“This is not a consumer level recall,” Jacobs tells WebMD. “This is not being undertaken on the basis of adverse events, but because we identified insufficiencies in the manufacturing process.”
Johnson & Johnson’s McNeil Consumer Healthcare unit says in a news release that the recall was ordered in consultation with the FDA for Children’s Benadryl Allergy Fastmelt Tablets in cherry and grape flavors.
The tablets were distributed in the U.S., Canada, Puerto Rico, St. Thomas, St. Martin, Barbados, and Belize, the company says.
The news release says the recall was ordered “after a review, conducted as part of McNeil’s comprehensive action plan, revealed insufficiencies in the development of the manufacturing process.”
It says “there is no indication that the recalled products do not meet quality standards.”
The McNeil unit says the recall includes all product lots of Junior Strength Motrin Caplets, 24 count, distributed in the U.S. It says there is no sign the caplets don’t meet quality standards and that the recall, like the one for Benadryl, is not being initiated due to any reports of adverse events.
Products being recalled are Children’s Benadryl Allergy Fastmelt Tablets, cherry flavor, with a code number of 50580-347-18; Children’s Benadryl Allergy Fastmelt Tablets, grape flavor, code number 50580-348-18; and Junior Strength Motrin Caplets, 24 count, code number 50580-498-24.
The company says consumers with questions should call 888-222-6036 Monday through Friday between 8 a.m. and 8 p.m. and Saturday and Sunday between 9 a.m. and 5 p.m. Eastern time.